ISO Class 7 (Class 10,000) Clean Room

HANSA has added medical device assembly and packaging to the list of capabilities.

The addition of the clean room will allow HANSA to truly be a turn-key option that is able to manufacture, clean and package your medical device instruments and implants.
We offer product assembly, pouch sealing and blister packaging that is capable of meeting even the most stringest packaging requirements.
The clean room has five (5) operational assembly and packaging lines capable of sealing product pouches as large as 18” wide. Hansa conducts  both peal and burst testing to insure the integrity of our seals. Hansa is capable of sealing poly/poly, poly/tyvec, foil/tyvec, or foil/foil.

The cleaning room has two separate temperature, humidity, and differential pressure monitoring systems that are backed up on a double redunant server to reduce or eliminate the possibility of data loss.The clean room is compliant to ISO 14644 standards and has been qualified by a third party certification company. Hansa conducts daily terminal cleans and monthly particulate monitor for both viable and non-viable particulate per the ISO standard. Hansa can provide pouches, labels, cartons, and/or any production material or the production and packaging material can be provided by our customers as an entire kit.

HANSA MEDICAL
ISO 13485:2003 certified